Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080426
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETACORT HYDROCORTISONE 1% LOTION;TOPICAL Discontinued None No No
CETACORT HYDROCORTISONE 0.5% LOTION;TOPICAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/22/1971 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/20/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/19/1994 SUPPL-10 Labeling

Label is not available on this site.

03/18/1992 SUPPL-9 Labeling

Label is not available on this site.

04/23/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/23/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/04/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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